Trial · NCT03118674
Harvoni Treatment Porphyria Cutanea Tarda
NCT03118674, Phase 2, Completed, Wake Forest University Health Sciences; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Harvoni Treatment Porphyria Cutanea Tarda. Trials, record NCT03118674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03118674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Harvoni Treatment Porphyria Cutanea Tarda
- NCT number
- NCT03118674
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Porphyria Cutanea Tarda, Hepatitis C
- Interventions
- Harvoni
- First posted
- 2017-04-18
- Last updated
- 2023-07-03
- Results first posted
- 2023-07-03
- Limitations and caveats
- We were not able to recruit as many subjects as we had originally planned and hoped to enroll \[original target n = 49\].
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy | 7 months | Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy |
| Secondary | Time to Resolution of Active PCT | through study completion, an average of 1 year | Time to resolution of active PCT, defined as cessation of any new blisters or bullae and normalization of plasma porphyrins |
| Secondary | Number of Participants With Complete Biochemical Remission of PCT | 12 Months | Defined as a decrease of the sum of urinary uro- and hepta-carboxyl porphyrins to less than 100 mcg/g creatinine and a normal urine porphyrin HPLC pattern defined as the total of highly carboxylated porphyrins (uro- and heptacarboxyl-porphyrins) being less than that of coproporphyrins, and the absence of a plasma fluorescence peak by fluorescence scanning |
| Secondary | Number of Participants With Cure of CHC | Up to 15 months | Defined as no detectable HCV RNA at end of treatment and persisting for at least 12 weeks after end of treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy | 7 months | 9 observations collected at 7 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Resolution of Active PCT | through study completion, an average of 1 year | Observations for 6 participants collected at through study completion, an average of 1 year | days | MEAN |
| SECONDARY | Number of Participants With Complete Biochemical Remission of PCT | 12 Months | 6 Observations collected at 12 Months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cure of CHC | Up to 15 months | 2 participants lost of follow up, 1 participant left the study after 4 weeks of dosing | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Resolution of Active PCT by 7 Months After Start of Therapy | Harvoni | 9 | Participants | ||
| Time to Resolution of Active PCT | Harvoni | 240 | Full Range 100 to 615 | days | |
| Number of Participants With Complete Biochemical Remission of PCT | Harvoni | 5 | Participants | ||
| Number of Participants With Cure of CHC | Harvoni | 11 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Harvoni | 23 | |
| Overall Study | COMPLETED | Harvoni | 8 | |
| Overall Study | NOT COMPLETED | Harvoni | 15 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Harvoni | 1 | 15 | 1 |
| other | Anxiety | Psychiatric disorders | Harvoni | 1 | 15 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Harvoni | 1 | 15 | 1 |
| other | Sinus pressure | General disorders | Harvoni | 1 | 15 | 1 |
| other | Infection | Infections and infestations | Harvoni | 1 | 15 | 2 |
| other | Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | Harvoni | 1 | 15 | 1 |
| other | Nasal congestion | General disorders | Harvoni | 1 | 15 | 1 |
| other | Neck pain | Musculoskeletal and connective tissue disorders | Harvoni | 1 | 15 | 1 |
| other | pain in both hands | Musculoskeletal and connective tissue disorders | Harvoni | 1 | 15 | 1 |
| other | Skin infection | Infections and infestations | Harvoni | 1 | 15 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Harvoni | 0 | 15 |
| Total, other adverse events | Harvoni | 1 | 15 |
| Total, serious adverse events | Harvoni | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36811718 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54DK083909 | Porphyrias Consortium | DESNICK, ROBERT J; BALWANI, MANISHA | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2009 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03118674
GET https://conductscience.org/api/trials/v1/NCT03118674/registered